Dome Patent, L.P. v. Rea (59 F. Supp. 3d 52, 2014)

OPINION, FINDINGS OF FACT AND CONCLUSIONS OF LAW

PAUL L. FRIEDMAN, United States District Judge

Dome Patent L.P. owns United States Patent No. 4,306,042 (the “Neefe Patent”), which was issued on December 15, 1981. The Neefe Patent is entitled “Method of Making a Contact Lens Material With Increased Oxygen Permeability,” and it is based on an application filed by Russell A. Neefe. See JTX-1. In 2007, the United States Patent and Trademark Office (the “PTO”) found that claim 1 of the Neefe Patent should be cancelled as obvious in light of the prior art. Dome timely filed a civil complaint under 35 U.S.C. §§ 145 and 306, requesting that this Court set aside the PTO’s decision. See Compl. ¶ 20. After considering the parties’ arguments, the administrative record, the decision of the PTO’s Board of Patent Appeals and Interferences, the evidence presented during a three-day bench trial, and the relevant legal authorities, the Court concludes that the process recited in claim 1 of the Neefe Patent is unpatentable, as it would have been obvious to a person of ordinary skill in the art at the time the patent application was filed. The Court therefore will enter judgment in favor of the defendant, Teresa Stanek Rea (“the Director”), Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the PTO.

I. BACKGROUND

A. The Neefe Patent and the Procedural History

The Neefe Patent contains four claims, the first of which is relevant to this action. Claim 1 recites:

A method of making an oxygen permeable material for the manufacture of contact lens [sic] by the synthesization of the monomer l,l,l-tris(methylsiloxy)me-thacryloxypropylsilane (a siloxanyl alkyl ester) by the following procedures:

(a) a mixture is prepared having the relationship of one mole of methacrylox-ypropyltrimethoxysilane with three to forty moles of trimethylchlorosilane;

(b) the mixture is then added to water whose volume is from 3 to 10 times that of the mixture;

(c) agitation is maintained for 30 minutes to 48 hours;

(d) then allow the mixture to separate into layers, remove and filter the upper organic layer;

(e) the unwanted by-product (hexame-thyldisiloxane) is then removed by vacuum distillation;

(f) forming an oxygen permeable contact lens material by copolymerizing from 5% to 90% by weight of the 1,1,1 tri$(trimethylsiloxy)methacryloxypro-pyl-silane prepared above; 3% to 90% by weight of an ester of acrylic or me-thacrylic acid; from 0.5% to 90% by weight of a surface wetting agent, from 0.01% to 90% by weight of an oxygen permeable crosslinking agent selected from the class of multifunctional siloxa-nyl alkyl esters in the presence of a free radical or a photo initiator.

JTX-1 at col.5 lines 38-64 (emphasis added); id., Certificate of Correction. Steps (a) through (e) of this claim recite a process for manufacturing a chemical compound commonly known as “Tris.” Step (f) describes a process for synthesizing Tris with three other compounds to create a rigid, gas permeable material suitable for manufacturing a contact lens.

In December 1997, Dome sought to enforce the Neefe Patent in an infringement action against several defendants. See Dome Patent L.P. v. Permeable Technologies, Inc., et al., Civil Action No. 98-6247 (filed in the Western District of New York, after being transferred from the Eastern District of California). One of these defendants, Optical Polymer Research, Inc., filed a request with the PTO for reexamination of the Neefe Patent. JTX-34 at 53-95 (Request for Reexamination, Aug. 27, 1998). On May 23, 2002, an examiner at the PTO concluded that claims 2, 3, and 4 of the Neefe Patent should be confirmed, but that claim 1 of the Neefe Patent— recited above — should be cancelled because the method it described “would have been obvious at the time the invention was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a); JTX-34 at 1110-20 (Office Action in Ex Parte Reex-animation). Dome timely appealed the examiner’s ruling to the Board of Patent Appeals and Interferences (the “Board”). JTX-34 at 1134-35 (Notice of Appeal dated July 12, 2002). On July 31, 2007, the Board issued an order affirming, the examiner’s decision. JTX-34 at 1270-93 (In re Neefe, Appeal 2007-1366).

On September 24, 2007, Dome timely filed this civil action pursuant to 35 U.S.C. §§ 145 and 306 for review of the Board’s decision. Compl.; Jt. Pretrial Stmt, at 3. The Court conducted a three-day bench trial from January 28 through January 30, 2013, during which the parties introduced the expert testimony of Timothy E. Long, Ph.D., Mark A. Melamed, M.D., and' William J. Benjamin, O.D., Ph.D., as well as testimony from the patent’s author, Robert A. Neefe. Dr. Long, called as a witness by Dome, is a professor of chemistry at the Virginia Polytechnic Institute and State University and an expert in the field of polymer chemistry. Dr. Melamed, also Dome’s witness, is an ophthalmologist with a large private practice in which he spends a substantial part of his time prescribing and fitting contact lenses. He also is a Professor of Ophthalmology at New York University School of Medicine. Dr. Melamed is an expert on the use and prescription of rigid gas permeable contact lenses and on the medical benefits of contact lenses with improved oxygen permeability. The Director’s expert, Dr. Benjamin, is a Professor of Optometry and Vision Science at the University of Alabama School of Optometry. He is an expert in the measurement of the oxygen permeability of contact lenses and the wettability of rigid contact lenses.

B. The Parties’ Positions

As discussed in the Findings of Fact below, many of the relevant facts in this case are undisputed. The parties agree that a usable hard contact lens must be clear, rigid, oxygen permeable, and wettable (i.e., hydrophilic). The parties also agree that the field of contact lens development witnessed a breakthrough in the 1970’s with the advent of rigid gas permeable lenses, which combined the clarity, rigidity, and wettability of one prior technology (PMMA lenses) with the oxygen permeability of another prior technology (soft silicone lenses). One of the lead inventors in this field, Norman Gaylord in New Providence, New Jersey, created the first commercially viable rigid gas permeable lens material using a novel “polymer,” composed of different “monomers.” In making this polymer, Gaylord began by using a silicone-containing monomer called Tris, which is very oxygen permeable but not wettable (that is, it is hydro phobic). Gaylord next added other monomers similar to those used in PMMA lenses, which are highly wettable but not oxygen permeable. Gaylord then joined the hydrophobic Tris monomers and the hydrophilic como-nomers together, using a hydrophilic cross-linking agent. This material could then be machined into a reasonably usable contact lens. Several other scientists subsequently refined and expanded on Gay-lord’s invention.

A few years later, a group of scientists led by Kyoichi Tanaka in Japan patented a different rigid gas permeable contact lens material using a non-Tris monomer with a range of cross-linking agents. One of Ta-naka’s preferred cross-linkers was a hydrophobic multifunctional siloxanyl alkyl ester, which is similar in molecular structure to the Tris monomer.

Less than two years later, Robert Neefe of Big Spring, Texas, combined the monomers used by Gaylord with the cross-linker used by Tanaka to develop a usable rigid gas permeable lens. Neefe’s process was patented as claim 1 of U.S. Patent No. 4,306,042, recited above and referred to here as the Neefe Patent.

This case centers on the parties’ disagreement as to whether it would have occurred to a person of ordinary skill in the art to do what Neefe did: to combine the first three compounds listed in step (f) of claim 1 of the Neefe Patent — ie., Gay-lord’s compounds — with the fourth compound listed in step (f) — i.e., Tanaka’s cross-linker. Dome contends that it would not have occurred to a person of ordinary skill to attempt this combination. According to Dome, one with ordinary skill would have been deterred from using both the Tris monomer from Gaylord and the Tris-type cross-linker from Tanaka in the same formulation, out of concern that the resulting compound would be unwetta-ble or otherwise unusable for contact lens production. See Dome’s Trial Brief at 10 (“[U]sing both a hydrophobic Tris monomer and a hydrophobic cross-linker would have been expected to yield a hydrophobic polymer that would be unsuitable as a contact lens material.”); id. at 9 (“Neefe offered a novel and counter-intuitive solution to the oxygen permeability problem: a polymer that contains both a hydrophobic Tris monomer and a hydrophobic Tris-type cross-linker.”) (emphasis in original). Dome also attempts to show that the success of a commercial contact lens made using the Neefe process demonstrates the nonobviousness of that process, supporting its patentability. Id. at 1 (describing evidence of “surprising and counter-intuitive results achieved by the method disclosed and claimed in the Neefe Patent” and “evidence of large scale commercial exploitation and use of -the method disclosed and claimed in the Neefe Patent”).

The Director disagrees, arguing that it was established that the hydrophobicity of both the Tris monomer and the Tris-type cross-linker could be offset by the hydro-philic monomers suggested by Gaylord, particularly within the broad ranges identified by Neefe. See Director’s Trial Brief at 28 (“Any concern about wettability arising from the use of a small amount of Tris (as low as 5% by weight), therefore, easily could be alleviated by use of a wetting agent (up to 90% by weight), while still remaining within the scope of the claim.”). And while the Director does not dispute that the contact lens referenced by Dome was commercially successful, she argues that this success cannot be attributed to the Neefe process for several reasons, and therefore any evidence of success is irrelevant to the question of obviousness. See id. at 5-7,13-14,16-25.

II. FINDINGS OF FACT

The following findings of fact are based on the evidence submitted by the parties during the bench trial, the administrative record before the Board, the Board’s opinion, the parties’ stipulations of undisputed facts, and the record as a whole.

A. The Polymer Chemistry of Contact Lens Material Production

a. Properties of Rigid Gas Permeable Contact Lenses

1. Claim 1 of the Neefe Patent recites a process for making material for the manufacture of a rigid gas permeable (“RGP”) contact lens. JTX-1 at [57] (Abstract).

2. A material for use in a RGP contact lens should have the following four characteristics: it should be optically clear; it should be hard and rigid; it should be wettable; and it should be oxygen permeable. Jan. 28 AM Tr. at 49:8-50:13 (Long); Jan. 29 AM Tr. at 14:25-16:7, 17:2-21, 100:9-11 (Melamed); Jan. 29 PM Tr. at 48:3-11 (Benjamin).

3. Optical clarity is important in order for the material to provide a clear visual image for the user. See Jan. 28 AM Tr. at 49:8-10 (Long); Jan. 29 PM Tr. at 48:3-7 (Benjamin).

4. Rigidity is required so that the lens can be machineable into a precise enough shape to provide crisp, consistent visual acuity. Jan. 28 AM Tr. at 49:16-21 (Long); Jan. 29 PM Tr. at 48:3, 48:7-11 (Benjamin).

5. Wettability, which is the interaction of water with a surface (such as the surface of a contact lens), is necessary for a contact lens to be comfortable on the eye of the wearer. Jan. 28 AM Tr. at 50:7-13 (Long); Jan. 29 AM Tr. at 15:12-16:7, 17:7-9 (Melamed).

6. Wettability is important because contact lenses do not actually sit on the surface of the cornea of the eye; instead, they float on a thin film of tears on the surface of the cornea. Jan. 29 AM Tr. at 14:12-14 & 15:19-23 (Melamed). Contact lenses must be tolerated in the eye without eliciting a painful foreign body sensation, so an even coating of tears must be spread across the surface of the lens. Id. at 15:12-16:3 (Melamed).

7. A hydro -phobic polymer is one that is water repellent, while a hydrophilic polymer can readily absorb water. Jan. 28 AM Tr. at 10:2 (Long); Jan. 30 AM Tr. at 13:25 (Benjamin).

8. Adequate oxygen permeability is necessary to prevent long-term damage to the eye of the wearer. Jan. 28 AM Tr. at 49:22-50:6 (Long); Jan. 29 AM Tr. at 14:25-15:11, 17:2-6, 17:19-21, 100:9-11 (Melamed).

9. Oxygen permeability is important because a constant flow of oxygen to the cornea is essential to avoid degenerative changes in its cells. Jan. 29 AM Tr. at 14:25-15:11 (Melamed). The cornea has no blood supply to bring it oxygen, so it gets its oxygen from the atmosphere, through the open lids of the eye. Jan. 29 AM Tr. at 14:14-17 (Melamed).

10. Anything that covers the cornea— either a contact lens or the eyelid — impedes the flow of oxygen to the cornea. Jan. 29 AM Tr. at 14:17-20 (Melamed). Thus, the oxygen flow to the cornea is impeded during sleep. Id. at 16:10-21 (Melamed).

11. Even with a contact lens in place, oxygen can reach the front surface of the cornea in two ways: (1) it can permeate through the body of the contact lens itself; or (2) it can be carried by tears around the edge of the contact lens. Jan. 29 AM Tr. at 14:20-24 (Melamed).

12. The oxygen permeability of a material is measured in Dk, or “barrers.” JTX-4 at 62; Jan. 29 AM Tr. at 25:22-23 (Melamed); Jan. 30 AM Tr. at 35:25 (Benjamin).

13. Ideally, a contact lens material will meet all four criteria: clarity, hardness, oxygen permeability, and wettability. Jan. 28 AM Tr. at 53:21-24 (Long). As Dome’s counsel noted at trial, these criteria can be remembered with the acronym “CHOW.” Jan. 28 AM Tr. at 9:7-8; see also Jan. 28 AM Tr. at 48:16r17 (Long).

b. The Polymer Chemistry Behind Contact Lens Manufacturing

14. The technology at issue in this case is the polymer chemistry required to manufacture RGP contact lenses.

15. A RGP contact lens is made from material that permits the passage of oxygen through the lens to the eye of the wearer. Jan. 29 AM Tr. at 40:9-10 (Me-lamed); JTX-4 at 63.

16. A “polymer,” also known as a “ma-cromolecule,” is a large molecule made up of many smaller units called “monomers.” JTX-3 at 3.

17. The process of synthesizing a polymer from monomers is called “polymerization.” JTX-3 at 3.

18. A “copolymer” is a type of polymer that is formed from two or more different types of monomers. JTX-3 at 7.

19. The process of synthesizing a copo-lymer is known as “copolymerization.” PTX-4, at tab 2; Director’s PFF. 14.

20. Polymers can take different forms, including linear, branched, and cross-linked (ie., networked). JTX-3 at 8-10. Illustrative examples of these different forms were provided -at trial and are reproduced below. See PTX-4 at Tab 3; Jan. 28 AM Tr. at 57:10-63:20 (Long)..

21. The materials that make up a polymer can alter the polymer’s chemical structure and therefore its physical properties. Jan. 28 AM Tr. at 63:1-20 (Long).

22. For example, the use of one cross-linking agent instead of another can affect the size of the gaps in the polymer’s structure, which can affect the polymer’s oxygen permeability. Jan. 28 AM Tr. at 62:3-63:20 (Long).

23.Cross-linked polymers can be exceptionally complex; the cross-linking agents may be close together or far apart, short or long, few or plentiful. Jan. 28 AM Tr. at 61:8-22 (Long).

B. The Prior Art: The Comonomers. Used by Neefe Were Known in the Prior Art and, When Used in Combination, Could Be Expected to Promote Oxygen Permeability

This case centers on a dispute about whether Neefe’s invention would have been obvious to a person of ordinary skill in the art, in light of the technology existing and known in the field at the time of Neefe’s invention — i.e., the prior art. Although the facts discussed in the section below are undisputed, the Court makes the following findings relating to the prior art and the Neefe Patent, with the purpose of providing background and context.

a. The Prior Art

24. The first practical plastic contact lens was made out of polymethyl metha-crylate (“PMMA”), which was first branded commercially as Plexiglas. See Jan. 28 AM Tr. at 50:25-51:1 (Long); Jan. 30 AM Tr. at 12:2-18 (Benjamin).

25. PMMA is a rigid, glass-like thermoplastic with relatively little flexibility. Jan. 28 AM Tr. at 51:9-10 (Long), 70:17-18; JTX-4 at 61-62.

26. PMMA is highly wettable, but it also is completely impermeable to oxygen. See Jan. 28 AM Tr. at 51:13-21 (Long); Jan. 30 AM Tr. at 12:2-18 (Benjamin).

27. This lack of oxygen permeability of PMMA lenses led to the development of so-called “contact lens over-wear syndrome” in users. Wearing these lenses for an extended period of time could cause pain, death of nerve endings in the cornea, blurred or filmy vision, glare, and halos around lights. Jan. 29 AM Tr. at 15:2-9 (Melamed); see also JTX-10 at col.l lines 28-32; Jan. 30 AM Tr. at 16:10-21 (Benjamin); JTX-27 at 279.

28.- In response to the problem of contact lens over-wear, many scientists began exploring polymers containing siloxanes for use in contact lens materials. Jan. 28 AM Tr. at 51:22-53:24 (Long); JTX-4 at 7, 60-63.

29. Siloxanes are chemical compounds containing carbon atoms (C), oxygen atoms (O), and silicon atoms (Si), in which two silicon atoms are bonded directly to one oxygen atom in the form -Si-O-Si-. JTX-4 at 60-62. The -Si-O-Si- chain can be thought of as the polymer’s backbone, to which other atoms and molecules are attached. Id.

PTX-4 at tab 8.

30.Siloxanes are highly oxygen permeable. They also, however, are hydrophobic — that is, water repellant. In addition, siloxanes are soft and difficult to machine. Jan. 28 AM Tr. at 52:10-25 (Long); Jan. 30 AM Tr. at 13:22-23 (Benjamin); JTX-4 at 17, 61-62; JTX-5 at 272; JTX-13 at col.l lines 33-34, 40-43.

31. A significant breakthrough in the field of contact lens materials took place in the 1970’s, when Norman G. Gaylord had the idea of using a rigid material for a contact lens that still allowed oxygen to pass through the lens to reach the cornea of the eye. Gaylord introduced the first RGP lens, an oxygen permeable contact lens made from a mixture of PMMA and silicone (siloxane). JTX-4 at 17; Jan. 29 AM Tr. at 22:24-25 (Melamed); id. at 53:19-24 (Melamed); see JTX-7; JTX-8.

32. In his invention, Gaylord combined four ingredients: (i) a silicone-based monomer; (ii) an acrylate; (iii) a wetting agent; and (iv) a cross-linking agent. Jan. 28 AM Tr. at 70:18-23 (Long); JTX-4 at 64; JTX-7 at col.l lines 57-60; JTX-8 at eol.1 lines 52-56, col.5 lines 39-46, col.6 lines 3-12; see Board Decision, JTX-16 at F.10.

33. In Gaylord’s polymer, the silicone is the chemical compound l,l,l-tris(trime-thylsiloxy)methacryloxypropylsilane, which is commonly known in the contact lens field as a “Tris” monomer. Jan. 28 AM Tr. at 69:11-70:5 (Long); JTX-1 at col.3 lines 13-14; JTX-4 at 63; JTX-7 at col.2 lines 26-35; JTX-8 at col.2 lines 32-44.

34. After Gaylord, the Tris monomer became the “industry standard” siloxy-me-thacrylate monomer in the field of RGP contact lenses. JTX-4 at 63.

35. Tris is a siloxanyl alkyl ester compound. Jan. 28 PM Tr. at 66:8 (Long); JTX-1 at col.3 lines 12-14, col.5 lines 40-41.

36. Tris is very hydrophobic, i.e., water repellant. Jan. 28 AM Tr. at 66:2-4, 74:20-21 (Long); JTX-6 at col.l lines 63-66.

37. In addition to Tris, Gaylord used methyl methacrylate (“MMA,” the monomer in.PMMA) as the acrylate, and he employed methacrylic acid as the wetting agent. Both MMA and methacrylic acid are hydrophilic: these comonomers therefore increased the wettability of the polymer. Jan. 28 AM Tr. at 67:3-12 (Long); Jan. 28 PM Tr. at 68:14-21 (Long); JTX-7 at col.3 line 29, col.4 lines 50-59; JTX-8 at col.3 line 65, col.5 lines 39-48; see also JTX-4 at 17.

38. The fourth ingredient, which Gay-lord used to bind these comonomers together, was a hydrophilic, non-siloxane based cross-linking agent, such as ethylene glycol dimethacrylate. Jan. 28 AM Tr. at 70:9-13 (Long); PTX-4 at Tab 9.

39. Contact lenses manufactured using the Gaylord polymer were introduced into the marketplace in the late 1970’s by Syn-tex, Inc. under the trade name Polycon. Jan. 30 AM Tr. at 40:2-7 (Benjamin); JTX-4 at 17; JTX-10 at col.2 lines 29-32;' JTX-12 at 238.

40. The first Polycon lens (Polycon I) had an oxygen permeability of approximately 5 Dk; the second (Polycon II), an oxygen permeability of approximately 10 to 12 Dk. The Polycon lenses thus exhibited much better oxygen permeability than PMMA lenses, which were completely impermeable. JTX-4 at 67; JTX-12 at 238; JTX-27 at 273.

41. Gaylord explains that the reason for the increased oxygen permeability of his lens materials is the inclusion of silicone (i.e., the use of the siloxanyl alkyl ester), which “is highly permeable to oxygen.” JTX-8 at eol.1 lines 81-32; see generally id. at eol.l lines 19-56.

42. At noted at FF. 30 and 36, although the presence of silicone improves the oxygen permeability of a contact lens material, it detracts from its wettability.

43. Gaylord addresses. the issue of wettability in his patent. He states that “[w]hile some of the copolymers [disclosed in his patent] are inherently wettable by human tears, it may be necessary to improve the wettability of others.” JTX-8 at eol.5 lines 39-41.

44. Gaylord discloses four alternate methods for improving the wettability of these copolymers, including adding hydro-philic monomers to the eopolymerization mixture and applying wetting agents to the surface of the contact lenses. JTX-8 at col.5 lines 42-58.

45. Although Gaylord’s invention represented a significant improvement in oxygen permeability, the first lenses incorporating Gaylord’s polymer still could not be used,for prolonged daily wear. See Jan. 29 AM Tr. at 91:13-92:8 (Melamed).

46. After Gaylord’s technique was known, several scientists worked to increase the oxygen permeability, wettability, and hardness of Gaylord’s formulation. See Jan. 28 AM Tr. at 73:10-79:10 (Long); see, e.g., JTX-9 at eol.l lines 11-41.

47. One pair of scientists — Edward J. Ellis and Joseph C. Salamone at Polymer Technology Corporation in Massachusetts — improved Gaylord’s technique by employing Tris but also adding an additional hydrophilic comonomer to improve the material’s wettability and structural integrity. Jan. 28 AM Tr. at 73:20-74:21 (Long); see generally JTX-9. Ellis applied for a patent based on this invention on February 15, 1978. JTX-9 at [22].

48. The Ellis patent was issued on May 1, 1979. It was later used to create the Boston II lens, which had an. oxygen permeability of approximately 12 to 14 Dk. JTX-9 at [45]; Jan. 29 AM Tr. at 25:22-25, 54:4-9 (Melamed); Jan. 30 AM Tr. at 69:25-70:2, 75:21-25 (Benjamin); JTX-4 at 66; JTX-12 at 238; JTX-21 at BL8556; JTX-27 at 273.

49. Another scientist, Nick N. Novicky of Wheeling, Illinois, attempted to solve the problems of the Gaylord polymers by replacing the Tris monomer with novel silicones of his own design. Jan. 28 AM Tr. at 75:23-25 (Long); see JTX-11 at col.3 lines 22-23, col.14 lines 37-45, col.18 lines 8-13.

50. Like Tris, the novel monomer employed by Novicky contains a methacrylate component and a tris(trimethylsiloxy) component. Jan. 28 AM Tr. at 76:22-77:9 (Long); JTX-11 at col.3 lines 49-53, col.3 lines 64-67, col.4 lines 25-39 (general formula), col.18 lines 28-39 (formula in claim 1).

51. Unlike Tris, the Novicky monomer contains an additional siloxane unit. JTX-11 at col.4 lines 25-39, col.18 lines 28-39; Jan. 28 AM Tr. at 76:1-4, 77:7-9 (Long).

52. This additional siloxane unit makes the novel Novicky monomer even more hydrophobic than Tris. Jan. 28 AM Tr. at 75:22-76:12 (Long).

53. In addition to the novel monomer, Novicky’s polymer also contains hydrophilic wetting agents and hydrophilic MMA. JTX-11 at col.3 lines 44-48, eol.6 line 65, col.7 line 27, col.18 lines 66-68, col.19 lines 1-3.

54. The Novicky polymer uses the same type of hydrophilic cross-linker used by Gaylord and Ellis; as noted supra at FF. 38, this cross-linker does not contain a siloxane group. JTX-11 at col.7 lines 15-24; Jan. 28 AM Tr. at 77:12-18 (Long).

55. The Novicky patent was issued on August 5,1980. JTX-11 at [45],

56. RGP contact lenses incorporating the Novicky polymer reportedly were marketed by Fused Contacts as the Sil-02-Flex lens. JTX-10 at col.8 line 23, col.8 line 38; JTX-12 at 238.

57. The Sil-02-Flex lens had an oxygen permeability level of approximately 5 to 8 Dk. JTX-10 at col. 8 line 38; JTX-12 at 238.

58. On September 22, 1978, a group of scientists led by Kyoichi Tanaka in Japan applied for a patent based on a novel polymer to be used for making an RGP contact lens. JTX-13 at [57].

59. Tanaka discloses that his copolym-ers have an excellent oxygen permeability and a good hydrophilic property (ie., they are wettable). Jan. 28 PM Tr. at 79:17-19 (Long).

60. Tanaka departed from Gaylord (and Ellis) in two ways. First, rather than using the Tris monomer, Tanaka employed a novel non-Tris silicone monomer containing siloxanylalkyl ester groups, which are hydrophobic, and internal glycerol or po-lyether groups, which are hydrophilic. Tanaka’s novel monomer thus was “amphi-philic,” and had a higher affinity for water — ie., was less water repellant — than the Tris monomer used by Gaylord and Ellis. Jan. 28 PM Tr. at 5:5-8, 5:13-14, 6:11-7:3, 9:14-21 (Long). Strands were then formed by polymerizing this novel non-Tris monomer and MMA as comonom-ers. Jan. 28 PM Tr.' at 5:3-8, 7:7-10 (Long); -JTX-13 at eol.7 lines 39-41.

61. Second, Tanaka proposed a variety of cross-linking agents, including some cross-linkers that were not employed by Gaylord and Ellis. Although Tanaka stated that, a cross-linker used by Gaylord, ethylene glycol dimethacrylate, could be used in his polymer, JTX-13 at col.8 lines 2-14, Tanaka’s “preferred” cross-linking agents were multifunctional siloxanyl alkyl esters having a siloxane bond (which he described as formula [IV] cross-linkers) and multifunctional siloxanyl alkanol esters, also having a siloxane bond (formula [V] cross-linkers). JTX-13 at col.8 lines 11-46; see also Jan. 28 PM Tr. at 77:25-78:22 (Long); JTX-16 at 5 (Board Finding No. 26).

62. Tanaka says that these cross-linking agents are preferred because the silox-ane bonds provide increased oxygen permeability to the cross-linked copolymer:

Since these cross-linking agents of the general formulas [V]- and [VI] have silox-ane bonds in their molecules, the oxygen permeability of the obtained cross-linked copolymers is high and, therefore, they are preferably employed in the present invention.

JTX-13 at col.8 lines 35-39; see Jan. 28 PM Tr. at 77:25-78:16 (Long); JTX-16 at 5-6 (Board Finding 27).

63. Tanaka states that the novel siloxa-nyl alkynol esters of formula [V] are “particularly useful” because they contain hy-drophilic hydroxyl groups. That is, not only do these cross-linkers promote a material’s oxygen permeability, but they also promote its wettability. JTX-13 at eol.8 lines 39-46.

64. The multifunctional siloxanyl alkyl esters referenced by Tanaka had been known in the field of polymer chemistry since at least 1958, and had been disclosed in the Mercker Patent, see PTX-1; Jan. 28 PM Tr. at 107:8-23 (Long), but there is no evidence that it had been purposely employed in contact lens production prior to Tanaka. See Jan. 28 PM Tr..at 107:8-108:6.

65. Tanaka’s patent was issued on November 25,1980. JTX-13 at [45].

b. The Neefe Invention

66. Beginning around 1977, Russell Neefe undertook to create a rigid gas permeable material suitable for contact lenses. Jan. 29 PM Tr. at 6:18-22 (Neefe).

67. At some point between 1977 and 1980, Neefe had the idea to cross-link the silicone-containing Tris monomer not with the cross-linkers used by Gaylord, Ellis, or Novicky, but with a cross-linking agent based on Tris. Jan. 29 PM Tr. at 15:16-23 (Neefe). This type of cross-linking agent — a multifunctional siloxanyl alkyl ester — was one of the agents preferred by Tanaka. See FF. 61-62.

68. The initial material created by Neefe using the process of claim 1 had a Dk value of 14. Jan. 29 PM Tr. at 19:15— 20:1 (Neefe).

69. On September 8, 1980, Russell Neefe submitted his application for the patent at issue in this suit. A patent was issued to Neefe on December 15, 1981. JTX-1 at [45].

70. The Neefe Patent is entitled “Method of Making a Contact Lens Material With Increased Oxygen Permeability.” JTX-1.

71. The Summary of Invention in the Neefe Patent- specification states that the “primary object of this invention is to provide a novel contact lens material which is prepared from a combination of monomers so as to have high oxygen, carbon dioxide permeability, and a hydrophilic surface.” JTX-1 at col.l lines 61-64.

72. The Neefe Patent contains four claims, three of which were not subject to reexamination because the PTO found no substantial question of patentability as to those claims. JTX-34 at 1112.

73. As noted supra at 56, claim 1 of the Neefe Patent outlines a six-step process for making a rigid gas permeable contact lens material, labeled (a) through (f). JTX-1 at col.5 lines 38-64.

74. The first five steps of the claim (steps (a)-('e)) recite a process of making l,l,l-tris(trimethylsiloxy)methacryloxypro-pylsilane, or “Tris.” JTX-1 at col.5 lines 44-54; JTX-16 at 2 (Board Findings 4-6); Jan. 28 AM Tr. at 69:1-70:5 (Long). There is no dispute that Tris was known in the prior art. Director’s PFF. 34; Dome’s Resp. PFF. 34.

75. Step (f) of the claim instructs that four chemical ingredients, including Tris, are combined to form “an oxygen permeable contact lens material.” JTX-1 at col.5 lines 55-64.

76. The four ingredients combined in step (f) are as follows: (1) “from 5% to 90% by weight” of the Tris monomer; (2) from “3% to 90% by weight of an ester of acrylic or methacrylic acid;” (3) “from 0.5% to 90% by weight of a surface wetting agent;” and (4) “from 0.01% to 90% by weight of an oxygen permeable crosslink-ing agent selected from the class of multifunctional siloxanyl alkyl esters.” JTX-1 at col.5 lines 55-64; id., Certificate of Correction.

77. The first three ingredients listed in step (f) of claim 1 of the Neefe patent were previously disclosed by Gaylord. The only significant difference between the contact lens material taught by Gaylord and the contact lens material in claim 1 of the Neefe Patent is the fourth ingredient: Gaylord’s material includes a hydrophilic cross-linking agent rather than the hydrophobic multifunctional siloxanyl alkyl ester used by Neefe. JTX-8 at col.6 lines 3-12; JTX-1 at col.2 lines 43-44 at col.5 lines 61-68; Jan. 28 PM Tr. at 16:3-5, 16:12-13, 17:4-10,18:2, 70:15-20 (Long).

78. As noted supra at FF. 61-63, Tana-ka suggested the use of a siloxanyl alkyl ester cross-linker in order to promote oxygen permeability, although Tanaka suggested its use with a different (non-Tris) monomer.

79. Four years later, Neefe created another material using the process of claim 1 of the Neefe Patent, which was commercialized and sold under the trade name TransAire. Jan. 30 AM Tr. at 79:25-80:4, 83:3-5 (Neefe). The TransAire polymer had a Dk value of 45. Jan. 30 AM Tr. at 81:15-18 (Neefe); JTX-27 at 273.

c. An Artisan of Ordinary Skill Would Have Known That Tris Monomer and a Siloxanyl Alkyl Ester Cross-Linker (like Tris Dimer or Trimer) Could Be Combined to Form an Oxygen Permeable Polymer

80. A person of ordinary skill in the art of making RGP contact lens materials, as of September 8, 1980, would have had at least an undergraduate degree — and very likely a graduate degree or some graduate training — in chemistry, coupled with experience in the development, manufacture and use of polymers suitable for the manufacture of RGP contact lenses. Jan. 28 PM Tr. at 60:15-19 (Long).

81. The person having ordinary skill in the art was aware of the reasons for and desirability of high oxygen permeability in contact lens materials. JTX-16 at 8 (Board Finding 50); see Director’s PFF. 46; Dome’s Resp. PFF. 46.

82. A person of ordinary skill in the art would have fully understood the copolym-erization chemistry used to make contact lens materials, including the mechanism involved in cross-linking different como-nomers. JTX-16 at 8:10-23; see Director’s PFF. 47; Dome’s Resp. PFF. 47; Dome’s PFF. 69; Director’s Resp. PFF. at 3, 5-6.

83. The person having ordinary skill in the art also would have understood and been familiar with the processes and chemistry for making the comonomers that are copolymerized in making contact lens materials. JTX-16 at 8 (Board Finding 53); see Director’s PFF. 49; Dome’s Resp. PFF. 49.

84. One having ordinary skill in the art would have been familiar with the properties of Tris and the chemistry necessary to make it. JTX-16 at 8 (Board Finding 54); see Director’s PFF. 50; Dome’s Resp. PFF. 50.

85. One having ordinary skill in the art would have understood that cross-linking takes place through terminal unsaturated carbon bonds. JTX-16 at 8, 16; see Director’s PFF. 48, 84; Dome’s Resp. PFF. 48, 84.

86. One having ordinary skill in the art would have understood that ethylene glycol dimethacrylate, described as a cross-linker by both Gaylord and Tanaka, may be represented by the following formula showing terminal unsaturated carbons (=CH2):

One having ordinary skill in the art would have understood that Tanaka’s preferred oxygen permeable cross-linkers similarly have terminal unsaturated carbons (=CH2). For example, the multifunctional siloxanyl alkyl esters employed by Tana-ka include those represented by the following general formula:

JTX-16 at 15 n.5; Director’s PFF. 83; Dome’s Resp. PFF. 83.

87. A person of ordinary skill in the art would have expected that these multifunctional siloxanyl alkyl ester cross-linking agents, having terminal unsaturated carbons (=CH2), would be effective cross-linking agents with the comonomers suggested by Gaylord. See JTX-16 at 16.

88. The person having ordinary skill in the art would have recognized that the oxygen permeability of Tanaka’s lens material was due in part to the use of Tana-ka’s preferred crosslinking agents, which contain siloxane bonds. See JTX-13 at col.8 lines 35-39; Jan. 28 PM Tr. at 79:15-16 (Long); see also JTX-16 at 6,14.

89. A person of ordinary skill in the art would reasonably expect that combining the comonomers suggested by Gaylord and the multifunctional siloxanyl alkyl ester cross-linking agent suggested by Tanaka would likely yield positive results in terms of oxygen permeability. See JTX-16 at 6 (Board Finding 28); Director’s PFF. 78-86; Dome’s Resp. PFF. 78-86 (asserting that an artisan of ordinary skill would have been deterred from combining Gaylord’s and Tanaka’s compounds for other reasons, but not disputing that such artisan would know that these materials could be combined to promote oxygen permeability); Dome’s Trial Brief at 4 (“It was known that incorporating a type of chemical called a ‘silicone’ (of which Tris is an example) in the contact lens material would improve its oxygen permeability.”).

C. A Person of Ordinary Skill in the Art Would Not Be Deterred, Because of Concern about Wettability or Opacity, from Using the Siloxanyl Alkyl Ester Monomor Suggested by Gaylord (Tris) with the Siloxanyl Alkyl Ester Cross-Linker Suggested by Tanaka

As noted, a person of ordinary skill in the art would have known that the multifunctional siloxanyl alkyl ester cross-linking agent referenced by Tanaka could be used with the Tris monomer, and that such combination would promote oxygen permeability. See FF. 89. Nevertheless, Dome maintains that the artisan of ordinary skill would have been dissuaded from using these materials together, due to the hydrophobic properties of both. See Jan. 30 PM Tr. at 8:2-9:18, 10:6-20 (Dome closing argument). The Director disagrees, arguing that the artisan of ordinary skill would know that she could offset the hydropho-bicity.of the two compounds by adding hydrophilic comonomers within the broad ranges identified by Neefe. Jan. 30 PM Tr. at 17:2-7; 18:14-20:6 (Director closing argument).

Upon consideration of the entire record, the Court finds as follows:

90. A person of ordinary skill in the art at the time of the invention would understand that any candidate material for making RGP contact lenses must simultaneously achieve design goals that are often in tension with one another. Jan. 28 PM Tr. at 61:5-10 (Long).

91. Tanaka teaches that polymers “consisting essentially of’ a siloxanyl alkyl ester (such as Tris) and having no hydrophilic groups have very strong water repelling properties and therefore are unsuitable for contact lenses. JTX-13 at col.3 lines 10-23.

92. Tanaka teaches that the water repelling nature of polysiloxanyl alkyl ester monomers can be repressed by reducing the number of hydrophobic alkylsiloxy groups in the polymer. Such reduction, however, will lead to a reduction in oxygen permeability:

In case of such a polysiloxanylalkyl ester monomer, when the water repelling property is repressed by reducing the number of the alkylsiloxy groups in the obtained polymer, the oxygen permeability becomes low, and then the oxygen permeability is raised by increasing the number of the alkylsiloxy groups in the obtained polymer, the water repelling property becomes strong. In any case, there cannot be obtained a polymer suited for preparing a contact lens which can be comfortably worn continuously for a long period of time.

JTX-13 at col.3 lines 41-51; see also Jan. 28 PM Tr. at 8:13-9:8 (Long).

93. Tanaka also warns that a polysilox-anyl alkyl ester monomer such as Tris could become opaque when combined with hydrophilic monomers.

[T]he polysiloxanylalkyl ester monomer may be copolymerized with a hydrophilic monomer to provide the obtained copo-lymer with a proper hydrophilic property, but since it is hard to copolymerize with the hydrophilic monomer, the copo-lymer is liable to become opaque. This is a fatal defect for use as contact lens materials. Therefore, the polymerization ratio of the hydrophilic monomer to the polysiloxanylalkyl ester monomer is limited to produce a transparent copo-lymer, and it is very difficult to decrease the water repelling property by copo-lymerizing with a hydrophilic monomer.'

JTX-13 at col.3 lines 23-41.

94. Tanaka sought to create a continuous wear lens (i.e., an extended or overnight wear lens), not a daily wear lens or a prolonged daily wear lens. JTX-13, Abstract (describing invention as contact lenses that “can be comfortably worn continuously for a long period of time”); id. at col.l lines 9-10; id. at col.l lines 31-32; id. at col.3 lines 50-51; id. at col.3 lines 60-63; id. at col.ll lines 4-5; id. at col.ll lines 13-14; id. at col.ll lines 50-52; id. at col.27 lines 43-65 (noting that Tanaka contact lenses “were worn on rabbit eyes continuously for 21 days,” and “could be continuously worn without change in eyes”).

95. “Continuous wear” is a term that is analogous to “extended wear,” where the individual continues to wear the same lens without interruption for several days, even while sleeping. Jan. 30 AM Tr. at 10:20-11:1 (Benjamin); see also Jan. 29 AM Tr. at 28:10-12 (Melamed).

96. The oxygen permeability of a contact lens worn in extended wear or continuous wear needs to be much greater than the oxygen permeability of a lens to be worn for daily wear. Jan. 30 AM Tr. at 21:20-24 (Benjamin).

97. Although Tanaka warned that it could be difficult to increase a Tris-based polymer’s wettability simply by adding hy-drophilic monomers, prior references in the art taught that hydrophilic monomers could be used, within limits, to offset hydrophobic monomers such as Tris.

98. For example, Gaylord discloses that other ingredients can be added to a siloxanyl alkyl ester to materially affect the basic properties of a contact lens material. Specifically, Gaylord discloses using from 30 to 90 parts by weight acrylic or methacrylic acid ester, JTX-8 at col.4 lines 14-16, both of which are hydrophilic. Jan. 28 PM Tr. at 64:11-19 (Long).

99. Gaylord also explains that, even if the resulting contact lens material is not sufficiently wettable on its own, “several alternate methods” can be used “to improve the wettability of’ contact lenses. JTX-8 at col.5 lines 39-58.

100. For example, “wettability can be imparted to the copolymer by the addition of from about 0.1% to about 10% by weight of one or more hydrophilic monomers.” JTX-8 at col.5 lines 42-45.

101. Gaylord also states that “the wett-ability of the surface of contact lenses made from the copolymers can be improved by the application of a wetting agent[,] ... by exposure of the surface to a corona discharge or by chemical treatment of the surface with a strong oxidizing agent such as nitric acid.” JTX-8 at col.5 lines 51-58.

102. Gaylord further describes that those methods are effective at yielding a wettable material — a lens made with 55 parts Tris (which is hydrophobic), 45 parts methyl methacrylate (which is hydrophilic), and 2 parts methacrylic acid (which is a hydrophilic wetting agent) “is readily wet-ted with a wetting agent solution.” JTX-8 at col.8 lines 5-19.

103. Gaylord also states that these materials will yield a “transparent” material, JTX-8 at col.8 lines 5-22, and thus Gay-lord teaches that Tris can be copolymer-ized with hydrophilic monomers like MMA and surface wetting agents without making the copolymer opaque.

104. In addition, Gaylord teaches that a material can contain relatively high amounts of hydrophobic monomers and still be wettable. For example, Gaylord discloses that lenses with as much as 70 parts by weight of Tris are wettable, even though Tris is hydrophobic. See JTX-8, Abstract; id. at col.l lines 17-18; id. at col. 12 line 50 (claiming material that is up to 70 parts by weight of Tris); id. at col.7 line 21 (disclosing material of 55 parts Tris); id. at col.7 line 38 (disclosing material of 60 parts Tris).

105. Claim 1 of the Neefe Patent permits as little as 0.01% of the hydrophobic crosslinking agent, along with 5% of Tris, which is hydrophobic, so it permits as much as 94.99% of hydrophilic comonom-ers. JTX-1 at col.5 lines 55-64. The pri- or art does not teach that a material composed 5% of Tris, .01% of a hydrophobic cross-linking agent, and 94.99% of hydro-philic comonomers would be unwettable. See FF. 102,104.

106. Dr. Long states that as of September 8, 1980, a person of ordinary skill in the art would not have reasonably expected that the siloxanyl alkyl ester cross-linker preferred by Tanaka could be used with a Tris-based polymer in order to create a contact lens. See Jan. 28 PM Tr. at 108:1-6. But this conclusion is not consistent with other evidence presented at trial. See FF. 90-105.

107. Dr. Long testified that he did not know what continuous wear or extended wear lenses are, and that such knowledge was beyond the scope of his synthetic polymer chemistry skills. Jan. 28 PM Tr. at 81:14-21 (Long). This lack of knowledge may have affected and limited Dr. Long’s understanding of Tanaka and his teachings.

108. In light of Findings of Fact 90 through 107, the Court finds that even if the Tanaka patent “teaches away” from the use of hydrophobic compounds such as Tris, it only discourages using such compounds when seeking to make a material that “can be comfortably worn continuously for a long period of time.” It did not teach away from using such compounds for daily wear or prolonged daily wear.

109. In light of Findings of Fact 90 through 108, the Court finds that a person of ordinary skill in the art would not be deterred, out of concerns about wettability or opacity, from using the Tris monomer suggested by Gaylord along with the silox-anyl alkyl ester cross-linker preferred by Tanaka to create a daily wear or prolonged daily wear contact lens, provided that other, hydrophilic comonomers also were employed.

D. Dome’s Evidence of Secondary Considerations

Dome argues that the process recited in claim 1 of the Neefe Patent satisfied a long-felt need for a contact lens that could be worn throughout the entire day. Dome notes that a variety of first generation lenses (such as Polycon II and Boston II) based on prior art could not be comfortably worn from when the wearer woke up in the morning until she went to bed in the evening. By contrast, the Boston TV lens, a second generation lens that Dome contends embodies claim 1 of the Neefe Patent, could be worn without interruption from morning until evening. The Boston IV lens achieved considerable commercial' success as compared to its predecessor, the Boston II lens, which Dome asserts was not manufactured in accordance with claim 1. Dome argues that the positive results achieved in the Boston IV lens and the ensuing commercial success provides objective evidence of the nonobviousness of • claim 1. See Jan. 30 PM Tr. at 12:6-13:10.

The Director maintains that many of the assumptions underlying Dome’s arguments are flawed. To begin with, the Director takes issues with Dome’s assertion that the Boston IV lens embodies claim 1 of the Neefe Patent, since the Boston IV process does not strictly comply with the sequence of steps for making Tris as specified in claim 1. Therefore, according the Director, the popularity of Boston TV cannot be used to shed light on the novelty of claim 1. The Director next argues that the success of the Boston IV lens was attributable to a number of factors, only one of which possibly relates to the Neefe Patent. Finally, the Director contends that the positive, commercially desirable properties of the Boston IV lens are unlikely to be present in other embodiments faffing within the claim’s broad range. Thus, even if the success of the Boston IV lens suggests that the process for the Boston TV lens was not obvious, the evidence is irrelevant to the obviousness of other processes faffing within the range of claim 1.

The parties’ disagreements turn both on questions of law and questions of fact. The factual disputes center on how a person of ordinary skill in the art would interpret the language of claim 1 of the Neefe. Patent; whether a person of ordinary skill in the art would view certain steps in the Boston IV and Boston II processes as equivalent to steps specified in claim 1; and the reasons for Boston IVs success. Upon consideration of the entire record, the Court finds as follows:

a. The Boston II and Boston IV Lenses

110. As noted supra at FF. 47-48, on May 1, 1979, a patent was issued for the invention of Edward J. Ellis and his colleague, working at the Polymer Technology Corporation (“PTC”), which is owned by Bausch & Lomb. JTX-9 at [54], [75], [45], [78].

111. Similar to, the Gaylord polymer, the Ellis polymer used the hydrophobic Tris monomer, a hydrophilic MMA monomer, a hydrophilic methacrylic acid as a wetting agent, and traditional, hydrophilic cross-linking agents. Jan. 28 AM Tr. at 73:25-74:2 (Long); 75:1-11; JTX-9 at col.3 line 68, col.4 lines 24-27, col.5 line 4, col.10 lines 28-33.

112. The Ellis polymer differed from the Gaylord polymer, however, in that Ellis added an additional hydrophilic monomer called itaconate in order to improve the stability and the wettability of the polymer. Jan. 28 AM Tr. at 73:10-16, 74:2-14 (Long); JTX-4 at 64; JTX-9 col.10 lines 28-33.

113. Contact lenses incorporating the Ellis polymer were introducéd into the marketplace in 1983 by PTC as the Boston II lens. JTX-10 at col.2 lines 48-51; PTX-3 at BL5513; see also JTX-4 at 64, 66.

114. A year later, in 1984, PTC introduced the Boston IV lens as part of a “second generation” of RGP contact lenses. Jan. 29 AM Tr. at 23:12-15, 55:5-7 (Melamed); Jan. 29 AM Tr. at 43:16-44:22.

115. Both the Boston II contact lens and the Boston IV contact lens are made from an oxygen permeable material formed by a process that includes the co-polymerization of Tris by procedures specified in Bausch & Lomb manufacturing protocols. JTX-21 at BL8556-57. Both procedures begin with the ' synthesis of TX-91, a specific formulation of Tris. Jan. 28 PM Tr. at 56:4-7 (Long); JTX-17 at BL31.

116. As discussed in FF. 117 to FF. 129, the five step process used to formulate TX-91 corresponds to steps (a) through (e) of the Neefe Patent.

b. Formulation of TX-91

117. First, the production of TX-91, a specific formulation of Tris, begins by mixing 600 mL methacryloxypropyltrimethox-ysilane (“MPS”) and 1200 mL trimethyl-chlorosilane (“TMCS”), for a molar ratio of TMCS to MPS of 3.75 to 1, in a 3 liter round bottom flask. JTX-18 at BL3, Step 7.1.2.

118. This process is performed in the exact manner as set forth in step (a) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 27:20-28:2 (Long); JTX-1 at col.5 lines 38-64.

119. Second, the mixture of MPS and TMCS is added to one-third volume of water and cooled with an external ice/water bath. JTX-18 at BL4, step 7.1.3-7.1.4.

120. This combined use of one-third volume of water (which catalyzes the hydrolysis reaction) and an external ice/water bath (which acts as a heat sink to absorb the excess heat produced in the exothermic reaction) is not performed in the exact manner as any step recited in the Neefe Patent. See JTX-1 at col.5 lines 38-64. This combined use performs substantially the same functions, however, as the 3 to 10-fold excess volume of water recited in step (b) of claim 1 of the Neefe Patent (i.e., catalyzing the hydrolysis reaction and absorbing excess heat), in substantially the same way (ie., by providing the water needed for incorporation during the chemical reaction and serving as a heat buffer), to achieve substantially the same result (i.e., forming Tris and limiting the formation of undesired by-products that can form under conditions of excessive heat). JTX-18 at BL4, step 7.1.3-7.1.4; Jan. 28 PM Tr. at 33:16-34:20 (Long); see also JTX-6 at col.l lines 52-54.

121. Third, the mixture of MPS, TMCS, and water is stirred slowly for 12 to 16 hours. Jan. 28 PM Tr. at 36:1-14 (Long); JTX-18 at BL4, Step 7.1.5.

122. This process is performed in the exact manner as set forth in step (c) of claim i of the Neefe Patent. Jan. 28 PM Tr. at 36:21-37:1 (Long); JTX-1 at col.5 lines 38-64.

123. Fourth, the mixture of MPS, TMCS, and water is transferred to a sep-aratory funnel, allowed to separate, and the upper organic layer is retained. Jan. 28 PM Tr. at 37:21-25, 38:1-5 (Long); JTX-18 at BL4, Step 7.1.6.

124. Fifth, volatiles (including the unwanted by-product hexamethyldisiloxane) are then removed under vacuum using a rotary evaporator or its equivalent. Jan. 28 PM Tr. at 39:17-40:1 (Long); JTX-18 at BL4, Step 7.1.9. The mixture is then filtered. Jan. 28 PM Tr. at 38:9-17 (Long); JTX-18 at BL5, Step 7.2.2. See generally JX-18.

125. The separation step and the vacuum distillation and filtration steps correspond to steps (d) and (e) of claim 1 of the Neefe Patent. The order in which each action is performed, however, differs from the sequence described in claim 1, which requires that the upper organic layer of the mixture is “remove[d] and filter[ed]” in step (d), and that the hexamethyldisiloxane “is then removed by vacuum distillation” in step (e). JTX-1 at col.5 lines 51-54 (emphasis added).

126. Nevertheless, a person of ordinary skill in the art would view filtration followed by vacuuming as equivalent to vacuuming followed by filtration. Jan. 28 PM Tr. at 40:12-15, 54:23-25, 87:8-9, 94:14-15 (Long). The Court bases this finding on the following facts:

a. Both the filtration process and the vacuum distillation process are used to purify the desired Tris by removing unwanted materials. Jan. 28 PM Tr. at 54:7-14 (Long).

b. Dr. Long testified that the presence of insoluble impurities or by-products will not alter the way in which the vacuum distillation process works, or its effectiveness in removing soluble materials. Jan. 28 PM Tr. at 54:7-14, 54:23-25 (Long). He also testified that the presence of unwanted soluble, organic impurities or byproducts will not alter the way in which the filtration process works, or its effectiveness in removing particulate materials. Jan. 28 PM Tr. at 54:7-14, 54:23-25 (Long).

c. No evidence was presented at trial indicating that the effectiveness of the filtration process depends on whether the filtration occurs before or after vacuum distillation; nor was any evidence presented that the effectiveness of the vacuum distillation process depends on whether distillation occurs before or after filtration.

127. After the five steps described above are completed, the resulting solution is TX-91. TX-91 consists of at least 85% Tris monomer; the remaining percentage is Tris dimer or trimer. JTX-17 at BL 81; Jan. 28 PM Tr. at 23:8-16 (Long).

128. Tris dimer and Tris trimer are both in the class of multifunctional siloxa-nyl alkyl esters required for step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:6-59:1 (Long).

129. TX-91 is the first ingredient used in both the Boston II manufacturing process and the Boston IV process. See generally JX-18; Jan. 28 PM Tr. at 56:4-13 (Long); Jan. 28 PM Tr. at 56:4-7 (Long). From this point, however, the Boston II process and the Boston IV process diverge.

c. The Boston II Lens

130. As noted, the first compound used in the Boston II copolymerization process is TX-91. Jan. 28 PM Tr. at 56:4-13 (Long).

131. TX-91, as prepared in steps (a) through (e) above, comprises approximately 41.7% by weight of the Boston II copo-lymer. JTX-17 at BL24, BL31. The main component of TX-91, the Tris monomer, therefore comprises 35.5% to 41.7% by weight of the Boston II copolymer. Jan. 28 PM Tr. at 56:14-15 (Long); JTX-17 at BL24, BL31.

132. This percentage of Tris falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28' PM Tr. at 56:18-57:1 (Long); JTX-1 at col.5 lines 38-64.

133. The second comonomer used in the copolymerization process is an ester of acrylic or methacrylic acid. Jan. 28 PM Tr. at 57:2-8 (Long).

134. An ester of acrylic or methacrylic acid comprises 21.8% by weight of the copolymer. JTX-17 at BL24, BL31.

135. This percentage of an ester of acrylic or methacrylic acid falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 57:2-12 (Long); JTX-1 at col.5 lines 38-64.

136. The third class of comonomers used in the copolymerization process are the surface wetting agents tetraethylene-glycol dimethacrylate (“CL”) and N-Nvi-nylpyrrolidone (“NVP”). Jan. 28 PM Tr. at 58:1-3 (Long).

137. Together, these surface wetting agents comprise 9.9% by weight of the copolymer. JTX-17 at BL24, BL31 (CL is 8.4% by weight; NVP is 1.5% by weight).

138. This percentage of surface wetting agents falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:1-5 (Long); JTX-1 at col.5 lines 38-64.

139. No additional multifunctional si-loxanyl alkyl esters are added to this mixture for the Boston II process. JTX-17 at BL 24, 31.

140. Multifunctional siloxanyl alkyl esters nevertheless are often present in the mixture used to create the Boston II lens. This is because, as noted supra at FF. 127-128, TX-91 consists of up to 15% Tris dimer or trimer, each of which is an example’ of the multifunctional siloxanyl alkyl ester called for in step (f) of claim 1. JTX-17 at BL 31; Jan. 28 PM Tr. at 23:8-16, 24:19-23, 98:18-99:3 (Long).

141. Neefe himself disclosed embodiments using Tris dimer or trimer as the crosslinking agent. Examples II and IV in the Neefe Patent specification employ a dimer of Tris. Jan. 28 PM Tr. at 17:24-18:2, 19:1-5 (Long); see also JTX-1 at col.3 lines 30-40, 62. Example VI of the Neefe Patent employs a trimer of Tris. JTX-1 at col.4 lines 36-37.

142. Because TX-91 makes up 41.7% of the Boston II lens by weight (JTX-17 at BL 24; Jan. 28 PM Tr. at 56:10-11 (Long)), the Boston II lens can be comprised up to 6.2% by weight of Tris dimer and trimer (i.e., 41.7% (percentage of TX-91 in the lens) multiplied by 15% (maximum percentage of Tris dimer and trimer in TX-91)). See Director’s PFF. 149; Dome Resp. PFF. 149.

143. PTC sought to minimize the presence of dimers and trimers in at least one of its formulations of Tris. JTX-19 at BL 68, 70. There is no evidence, however, that the amount of Tris dimer or trimer was minimized below .01 % by weight. In fact, PTC calculated that the Boston II lens contained ‘approximately 1.3 mole percent of Tris dimer and trimer. JTX-21 at 8557, 8577.

144. If Tris dimer and trimer are present in TX-91, then they will be cross-linked in the copolymer. Jan. 28 PM Tr. at 97:18-98:6 (Long).

145. As noted supra at FF. 76, step (f) of claim 1 of the Neefe Patent requires that at least .01 % of the hydrophobic cross-linking agent — such as Tris dimer or Tris trimer — be copolymerized with the Tris, the ester of acrylic or methaerylic acid, and the surface wetting agent. JTX-1 at col.5 lines 55-64.

146. The maximum amount of Tris dimer and trimer permitted in the Boston II lens — 6.2%—falls well within the “0.01 % to 90%” range of siloxanyl alkyl ester cross-linking agent required in Step (f) of claim 1 of the Neefe Patent. See JTX-1 at col.5 lines 55-64.

147. The minimum amount of Tris dimer and Tris permitted in the Boston II lens — 0%—falls narrowly outside of the “0.01 % to 90%” range of siloxanyl alkyl ester cross-linking agent required in Step (f) of claim 1 of the Neefe Patent. See id.

148. As noted supra at FF. 48, the oxygen permeability of the Boston II lenses consistently was reported to be approximately 12 to 14 Dk. Jan. 29 AM Tr. at 25:22-25, 54:4-9 (Melamed); Jan. 30 AM Tr. at 69:25-70:2, 75:21-25 (Benjamin); JTX-4 at 66 (12-14 Dk); JTX-12 at 238 (12.6 Dk); JTX-21 at BL8556 (14.6 Dk); JTX-27 at 273 (12 Dk); PTX-2 at BL4760 (14.6 Dk); but see JTX-20 at BL8328 (16.4 Dk).

d. The Boston IV Lens

149. Like the Boston II lens, the first compound employed in the Boston IV co-polymerization process is TX-91. Jan. 28 PM Tr. at 56:4-7 (Long); JTX-17 at BL31.

150. Sufficient amounts of TX-91 are used so that the Tris monomer comprises 38.3% to-41.0% by weight of the copolymer. JTX-17 at BL31; Jan. 28 PM Tr. at 56:14-15 (Long).

151. This percentage of Tris monomer falls within the range specified in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 56:18-57:1 (Long).

152. As in the Boston II process, the second comonomer employed in the copo-lymerization set forth in the Boston IV process is an ester of acrylic or, methacrylic acid. Jan. 28 PM Tr. at 57:2-8 (Long).

153. An ester of acrylic or methacrylie acid comprises 19.7% by weight of the copolymer used for the Boston IV process. JTX-17 at BL24, BL31.

154. This amount of ester of acrylic or methacrylie acid falls within the range specified in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 57:2-12 (Long).

155. As in the Boston II process, the third class of comonomers employed in the copolymerization set forth in the Boston TV process are the surface wetting agents tetraethylene glycol dimethacrylate and N-Nvinylpyrrolidone. Jan. 28 PM Tr. at 58:1-3 (Long).

156. Together, these surface wetting agents comprise- 8.1% by weight of the copolymer. JTX-17 at BL24, BL31 (CL is 2.9% by weight; NVP is 5.5% by weight).

157. This percentage of surface wetting agents falls within the range specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:1-5 (Long).

158. Unlike in the Boston II process, in the Boston IV process TX-91 is modified to become TX-82. TX-82 is prepared by adding substantial quantities of Tris dimer and Tris trimer to the TX-91 formulation produced through steps (a) through (e), so as to increase the percentage of Tris dimer to between 19.5 and 21 percent ánd Tris trimer to between 3 and 9.5 percent. Jan. 28 PM Tr. at 24:5-18, 58:2